US2025003979A1PendingUtilityA1

Metabolomic profiles for prediction of functional neurological outcome or death following severe traumatic brain injury

50
Assignee: UTI LPPriority: Jul 9, 2021Filed: Jul 11, 2022Published: Jan 2, 2025
Est. expiryJul 9, 2041(~15 yrs left)· nominal 20-yr term from priority
G01N 2800/56G01N 2800/2871G01N 2570/00G01N 33/6806G01N 33/66G01N 33/5308G01R 33/465G01N 2800/52G01N 33/6896G01N 33/6848
50
PatentIndex Score
0
Cited by
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Claims

Abstract

The present disclosure provides a method of determining a likelihood of a favorable or unfavorable outcome, such as death or a Glasgow Outcome Scale Extended (GOSE) score≤4, in a subject having severe traumatic brain injury (sTBI). The method involves quantitative assessment of multiple metabolites shortly after the injury, such as on day 1 and/or day 4 for changes indicative of outcome. Quantitative mass spectrometry (MS) or proton (1H) nuclear magnetic resonance spectroscopy (NMR) may be used to assess multiple metabolites within a single blood sample for comparison with a control.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method of determining a likelihood of an unfavourable outcome in a subject having a severe traumatic brain injury (sTBI), comprising:
 obtaining a sample from a subject at day 1 and/or day 4 post sTBI,   measuring an amount of a plurality of metabolites in the sample, and   comparing levels of the plurality of metabolites in the sample with a control;   wherein an outcome of the comparing step is an increase or decrease in quantity of said plurality of metabolites in the sample relative to the control, and   wherein unfavourable outcome is determined as likely when:   in the day 1 sample, at least two, or at least 5, of the following metabolites of the plurality of metabolites are changed relative to the control: C3:1, LYSOC17:0, LYSOC18:0, LYSOC16:0, C18:2, LYSOC18:1, C14, C18:1, C18, C16, tyrosine, homocysteine, C3, CO, C4, ornithine, LYSOC14:0, SM 16:1 OH, LYSOC20:3, LYSOC28:1, phenylalanine, glutamine, PC ae 36:0, histidine, SM 20:2, isoleucine, citrulline, methionine-sulfoxide, asymmetric dimethylarginine, C5OH, C10:2, acetyl-ornithine, C9, methionine-sulfoxide, spermine, serotonin, serine, trans-hydroxyproline, succinate, gluconate, acetone, lactate, glycerol, betaine, choline, alanine, and 3-hyroxyisovalerate;   and/or   in the day 4 sample, at least two, or at least 5, of the following metabolites of the plurality of metabolites are changed relative to the control: valine, N-acetylaspartate, tyrosine, lysine, dimethylsulfone, taurine, gluconate, hypoxanthine, beta-alanine, C3OH, glutamic acid, LYSOC18:0, PC36:0AA, C18:2, C3:1, C3, ornithine, CO, SM 16:1 OH, LYSOC14:0, LYSOC20:3, homocysteine, C16:1, glutamine, beta-hydroxybutyric acid, uric acid, serotonin, C9, PC ae 36:0, methionine-sulfoxide, serine, a-dimethylarginine, spermine, and trans-hydroxyproline;   wherein the unfavourable outcome comprises a Glasgow Outcome Scale Extended (GOSE) score≤4 from 3 months to 12 months post sTBI.   
     
     
         2 . The method of  claim 1 , wherein said likelihood of said unfavorable outcome is determined for three months following the sTBI. 
     
     
         3 . The method of  claim 1 , wherein said likelihood of said unfavorable outcome is determined for twelve months following the sTBI. 
     
     
         4 . The method of  claim 1 , wherein said likelihood of said unfavorable outcome is determined from a Day 1 sample, with an increase or decrease in the at least two, or the at least 5, metabolites as per Tables 35A, 35B, 37A, or 37B: 
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   Lyso PC 17:0 
                   Up 
                 
                     
                   Lyso PC 18:0 
                   Up 
                 
                     
                   C3:1 
                   Up 
                 
                     
                   Lyso PC 16:0 
                   Up 
                 
                     
                   Lyso PC 18:1 
                   Up 
                 
                     
                   C18:2 
                   Up 
                 
                     
                   C14 
                   Up 
                 
                     
                   C18 
                   Up 
                 
                     
                   C18:1 
                   Up 
                 
                     
                   C16 
                   Up 
                 
                     
                   C14:2 
                   Up 
                 
                     
                   Tyrosine 
                   Down 
                 
                     
                   Asparagine 
                   Down 
                 
                     
                   PC ae 36:0 
                   Down 
                 
                     
                   C16:2 
                   Down 
                 
                     
                   Phenylalanine 
                   Down 
                 
                     
                   C16:1 
                   Down 
                 
                     
                   Glutamine 
                   Down 
                 
                     
                   SM 20:2 
                   Down 
                 
                     
                   PC aa 32:2 
                   Down 
                 
                     
                   Isoleucine 
                   Down 
                 
                     
                   Citrulline 
                   Down 
                 
                     
                   Histidine 
                   Down 
                 
                     
                   Glutamate 
                   Down 
                 
                     
                   Methionine-Sulfoxide 
                   Down 
                 
                     
                   Asymmetric 
                   Down 
                 
                     
                   dimethylargine 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   LYSOC17:0 
                   Up 
                 
                     
                   LYSOC18:0 
                   Up 
                 
                     
                   LYSOC16:0 
                   Up 
                 
                     
                   C18:2 
                   Up 
                 
                     
                   C14 
                   Up 
                 
                     
                   C18:1 
                   Up 
                 
                     
                   C18 
                   Up 
                 
                     
                   C16 
                   Up 
                 
                     
                   Glutamine 
                   Down 
                 
                     
                   Histidine 
                   Down 
                 
                     
                   SM 20:2 
                   Down 
                 
                     
                   Methionine-sulfoxide 
                   Down 
                 
                     
                   Asymmetric 
                   Down 
                 
                     
                   dimethylarginine 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   C5OH 
                   Down 
                 
                     
                   Homocysteine 
                   Up 
                 
                     
                   C3 
                   Up 
                 
                     
                   C0 
                   Up 
                 
                     
                   C4 
                   Up 
                 
                     
                   Ornithine 
                   Up 
                 
                     
                   LYSOC14:0 
                   Up 
                 
                     
                   SM 16:1 OH 
                   Up 
                 
                     
                   LYSOC20:3 
                   Up 
                 
                     
                   LYSOC28:1 
                   Up 
                 
                     
                   C10:2 
                   Down 
                 
                     
                   Acetyl-ornithine 
                   Down 
                 
                     
                   C9 
                   Down 
                 
                     
                   Adimethylarginine 
                   Down 
                 
                     
                   Methionine-sulfoxide 
                   Down 
                 
                     
                   Spermine 
                   Down 
                 
                     
                   PC ae 36:0 
                   Down 
                 
                     
                   Citrulline 
                   Down 
                 
                     
                   Serotonin 
                   Down 
                 
                     
                   Serine 
                   Down 
                 
                     
                   trans-Hydroxyproline 
                   Down 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   C3 
                   Up 
                 
                     
                   Ornithine 
                   Up 
                 
                     
                   C0 
                   Up 
                 
                     
                   SM 16:1 OH 
                   Up 
                 
                     
                   LYSOC14:0 
                   Up 
                 
                     
                   LYSOC20:3 
                   Up 
                 
                     
                   Homocysteine 
                   Up 
                 
                     
                   Serotonin 
                   Down 
                 
                     
                   C9 
                   Down 
                 
                     
                   PC ae 36:0 
                   Down 
                 
                     
                   Methionine-sulfoxide 
                   Down 
                 
                     
                   Serine 
                   Down 
                 
                     
                   Adimethylarginine 
                   Down 
                 
                     
                   Spermine 
                   Down 
                 
                     
                   trans-Hydroxyproline 
                   Down 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
     
     
         5 . The method of  claim 1 , wherein said likelihood of said unfavorable outcome is determined from a Day 4 sample, with an increase or decrease in the at least two, or the at least 5, metabolites as per Tables 36A, 36B, 38A, or 38B: 
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   C3OH 
                   Up 
                 
                     
                   Glutamic acid 
                   Up 
                 
                     
                   LYSOC18:0 
                   Up 
                 
                     
                   Ornithine 
                   Up 
                 
                     
                   PC aa3 6:0 
                   Up 
                 
                     
                   C18:2 
                   Up 
                 
                     
                   alpha-Aminoadipic acid 
                   Up 
                 
                     
                   Indole acetic acid 
                   Up 
                 
                     
                   C3:1 
                   Up 
                 
                     
                   PC aa 40:2 
                   Down 
                 
                     
                   C16:1 
                   Down 
                 
                     
                   Serine 
                   Down 
                 
                     
                   Glutamine 
                   Down 
                 
                     
                   beta-Hydroxybutyric acid 
                   Down 
                 
                     
                   Uric acid 
                   Down 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   C3OH 
                   Up 
                 
                     
                   Glutamic acid 
                   Up 
                 
                     
                   LYSOC18:0 
                   Up 
                 
                     
                   Ornithine 
                   Up 
                 
                     
                   PC36:0AA 
                   Up 
                 
                     
                   C18:2 
                   Up 
                 
                     
                   C3:1 
                   Up 
                 
                     
                   C16:1 
                   Down 
                 
                     
                   Glutamine 
                   Down 
                 
                     
                   beta-Hydroxybutyric acid 
                   Down 
                 
                     
                   Uric acid 
                   Down 
                 
                     
                   C6 
                   Up 
                 
                     
                   C3 OH 
                   Up 
                 
                     
                   C18:1 OH 
                   Up 
                 
                     
                   Tryptophan 
                   Up 
                 
                     
                   C3:1 
                   Up 
                 
                     
                   Tyrosine 
                   Up 
                 
                     
                   Creatinine 
                   Up 
                 
                     
                   LysoPC 14:0 
                   Up 
                 
                     
                   Alanine 
                   Up 
                 
                     
                   C16 
                   Up 
                 
                     
                   C2 
                   Down 
                 
                     
                   C14 
                   Down 
                 
                     
                   Beta-hydroxy butyric 
                   Down 
                 
                     
                   Spermine 
                   Down 
                 
                     
                   Betaine 
                   Down 
                 
                     
                   C14:2 
                   Down 
                 
                     
                   Aspartic acid 
                   Down 
                 
                     
                   C18 
                   Down 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   C6 
                   Up 
                 
                     
                   C3 OH 
                   Up 
                 
                     
                   Tryptophan 
                   Up 
                 
                     
                   C3:1 
                   Up 
                 
                     
                   Tyrosine 
                   Up 
                 
                     
                   Creatinine 
                   Up 
                 
                     
                   LysoPC 14:0 
                   Up 
                 
                     
                   C14 
                   Down 
                 
                     
                   Beta-hydroxy butyric 
                   Down 
                 
                     
                   Betaine 
                   Down 
                 
                     
                   C14:2 
                   Down 
                 
                     
                   Aspartic acid 
                   Down 
                 
                     
                   C18 
                   Down 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
     
     
         6 . A method of determining a likelihood of mortality within three months in a subject having a severe traumatic brain injury (sTBI), comprising:
 obtaining a sample from a subject at day 1 and/or day 4 post sTBI,   measuring an amount of a plurality of metabolites in the sample, and   comparing levels of the plurality of metabolites in the sample with a control,   wherein an outcome of the comparing step is an increase or decrease in quantity of said plurality of metabolites in the sample relative to the control, and   wherein increased likelihood of mortality is determined when:   in the day 1 sample, at least two, or at least 5, of the following metabolites of the plurality of metabolites are changed relative to the control: C3:1, PC aa 38:0, glucose, C16:2, leucine, C10:2, valine, isoleucine, histidine, C16OH, glutamine, betaine, 3-hydroxyisovalerate, citrate, and lactate;   and/or   in the day 4 sample, at least two, or at least 5, of the following metabolites of the plurality of metabolites are changed relative to the control: isobutyrate, valine, lysine, 2-aminobutyrate, hypoxanthine, taurine, gluconate, betaine, alpha-ketoglutaric acid, C16:2OH, hippuric acid, indole acetic acid, PC aa 36:0, ornithine, PC aa 38:0, alpha-aminoadipic acid, tryptophan, leucine, C12:1, C6, glutamine, and LysoPC 26:0.   
     
     
         7 . The method of  claim 6 , wherein said likelihood of mortality is determined from a Day 1 sample, with increase or decrease in said at least 2, or said at least 5, of the plurality of metabolites as per Tables 43A, 43B, 45A, or 45B: 
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   C3:1 
                   Up 
                 
                     
                   PC aa 38:0 
                   Up 
                 
                     
                   Glucose 
                   Up 
                 
                     
                   PC ae 40:6 
                   Up 
                 
                     
                   C10:1 
                   Up 
                 
                     
                   C14:1 
                   Up 
                 
                     
                   C14 
                   Up 
                 
                     
                   C10 
                   Up 
                 
                     
                   C16:2 
                   Up 
                 
                     
                   C8 
                   Up 
                 
                     
                   C12 
                   Up 
                 
                     
                   Citrulline 
                   Down 
                 
                     
                   C10:2 
                   Down 
                 
                     
                   Leucine 
                   Down 
                 
                     
                   Valine 
                   Down 
                 
                     
                   Isoleucine 
                   Down 
                 
                     
                   Histidine 
                   Down 
                 
                     
                   C16 OH 
                   Down 
                 
                     
                   Glutamine 
                   Down 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   C3:1 
                   Up 
                 
                     
                   PC aa 38:0 
                   Up 
                 
                     
                   Glucose 
                   Up 
                 
                     
                   C16:2 
                   Up 
                 
                     
                   Leucine 
                   Down 
                 
                     
                   C10:2 
                   Down 
                 
                     
                   Valine 
                   Down 
                 
                     
                   Isoleucine 
                   Down 
                 
                     
                   Histidine 
                   Down 
                 
                     
                   C16 OH 
                   Down 
                 
                     
                   Glutamine 
                   Down 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   Glucose 
                   Up 
                 
                     
                   Betaine 
                   Up 
                 
                     
                   3-Hydroxyisovalerate 
                   Up 
                 
                     
                   Citrate 
                   Up 
                 
                     
                   O-Phosphocholine 
                   Up 
                 
                     
                   Dimethyl Sulfone 
                   Up 
                 
                     
                   Formate 
                   Up 
                 
                     
                   Fumarte 
                   Up 
                 
                     
                   2-Oxglutarate 
                   Up 
                 
                     
                   Pyruvate 
                   Up 
                 
                     
                   Lactate 
                   Down 
                 
                     
                   Valine 
                   Down 
                 
                     
                   Isoleucine 
                   Down 
                 
                     
                   Leucine 
                   Down 
                 
                     
                   Diemthylamine 
                   Down 
                 
                     
                   Glutamine 
                   Down 
                 
                     
                   Histidine 
                   Down 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   Glucose 
                   Up 
                 
                     
                   Betaine 
                   Up 
                 
                     
                   3-Hydroxyisovalerate 
                   Up 
                 
                     
                   Citrate 
                   Up 
                 
                     
                   Lactate 
                   Down 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
               
            
           
         
       
     
     
         8 . The method of  claim 6 , wherein said likelihood of mortality is determined from a Day 4 sample, with an increase or decrease in said at least 2, or said at least 5, of the plurality of metabolites as per Tables 44A, 44B, 46A, 46B, or 46C: 
       
         
           
                 
                 
                 
                 
               
                     
                     
                 
                     
                     
                   Indole acetic acid 
                   Up 
                 
                     
                     
                   Alpha-Ketglutaric acid 
                   Up 
                 
                     
                     
                   Hippric acid 
                   Up 
                 
                     
                     
                   C16:2 OH 
                   Up 
                 
                     
                     
                   Ornithine 
                   Up 
                 
                     
                     
                   PC aa 36:0 
                   Up 
                 
                     
                     
                   C3 
                   Up 
                 
                     
                     
                   Threonine 
                   Up 
                 
                     
                     
                   Alpha-Aminoadipic acid 
                   Up 
                 
                     
                     
                   PC aa 38:0 
                   Up 
                 
                     
                     
                   Tyrosine 
                   Up 
                 
                     
                     
                   Valine 
                   Up 
                 
                     
                     
                   Tryptophan 
                   Up 
                 
                     
                     
                   C2 
                   Down 
                 
                     
                     
                   C8 
                   Down 
                 
                     
                     
                   C12:1 
                   Down 
                 
                     
                     
                   Betaine 
                   Down 
                 
                     
                     
                   C6 
                   Down 
                 
                     
                     
                   Glutamine 
                   Down 
                 
                     
                     
                   Taurine 
                   Down 
                 
                     
                     
                   LysoPC 26:0 
                   Down 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
       
         
           
                 
                 
                 
                 
               
                     
                     
                 
                     
                     
                   Alpha-Ketoglutaric acid 
                   Up 
                 
                     
                     
                   C16:2 OH 
                   Up 
                 
                     
                     
                   Hippuric acid 
                   Up 
                 
                     
                     
                   Indole acetic acid 
                   Up 
                 
                     
                     
                   PC aa 36:0 
                   Up 
                 
                     
                     
                   Ornithine 
                   Up 
                 
                     
                     
                   PC aa 38:0 
                   Up 
                 
                     
                     
                   Alpha-Aminoadipic acid 
                   Up 
                 
                     
                     
                   Tryptophan 
                   Up 
                 
                     
                     
                   Valine 
                   Down 
                 
                     
                     
                   Leucine 
                   Down 
                 
                     
                     
                   C12:1 
                   Down 
                 
                     
                     
                   C6 
                   Down 
                 
                     
                     
                   Glutamine 
                   Down 
                 
                     
                     
                   LysoPC 26:0 
                   Down 
                 
                     
                     
                   Taurine 
                   Down 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
       
         
           
                 
                 
                 
                 
               
                     
                     
                 
                     
                     
                   Isobutyrate 
                   Up 
                 
                     
                     
                   Creatine 
                   Up 
                 
                     
                     
                   Creatinine 
                   Up 
                 
                     
                     
                   Valine 
                   Up 
                 
                     
                     
                   Lysine 
                   Up 
                 
                     
                     
                   Asparagine 
                   Up 
                 
                     
                     
                   Leucine 
                   Up 
                 
                     
                     
                   Tyrosine 
                   Up 
                 
                     
                     
                   2-Aminobutyrate 
                   Up 
                 
                     
                     
                   4-Hydroxybutyrate 
                   Down 
                 
                     
                     
                   Methionine 
                   Down 
                 
                     
                     
                   Urea 
                   Down 
                 
                     
                     
                   Hypoxanthine 
                   Down 
                 
                     
                     
                   Taurine 
                   Down 
                 
                     
                     
                   Gluconate 
                   Down 
                 
                     
                     
                   Betaine 
                   Down 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
       
         
           
                 
                 
                 
                 
               
                     
                     
                 
                     
                     
                   Isobutyrate 
                   Up 
                 
                     
                     
                   Valine 
                   Up 
                 
                     
                     
                   Lysine 
                   Up 
                 
                     
                     
                   2-Aminobutyrate 
                   Up 
                 
                     
                     
                   Hypoxanthine 
                   Down 
                 
                     
                     
                   Taurine 
                   Down 
                 
                     
                     
                   Gluconate 
                   Down 
                 
                     
                     
                   Betaine 
                   Down 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
               
            
           
         
       
       
         
           
                 
                 
                 
                 
               
                     
                     
                 
                     
                     
                   Valine 
                   Up 
                 
                     
                     
                   Lysine 
                   Up 
                 
                     
                     
                   Taurine 
                   Down 
                 
                     
                     
                   Gluconate 
                   Down 
                 
                     
                     
                   Betaine 
                   Down. 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
               
            
           
         
       
     
     
         9 . A method of determining a likelihood of an outcome in a subject having a severe traumatic brain injury (sTBI) or suspected of having an sTBI, comprising:
 obtaining a sample from a subject at day 1 or day 4 post-sTBI,   measuring an amount of a plurality of metabolites in the sample, and comparing levels of the plurality of metabolites in the sample with a control, wherein an outcome of the comparing step is an increase or decrease in quantity of said plurality of metabolites in the sample,   (i) wherein the likelihood of unfavourable outcome at 3 months is determined:
 (a1) in a day 1 sample assessed by quantitative MS, wherein at least 2, at least 5, or at least 10 metabolites of said plurality of metabolites are increased or decreased relative to the control as indicated of the 26 metabolites in Table 35A: 
   
       
         
           
                 
                 
                 
                 
               
                     
                     
                 
                     
                     
                   Lyso PC 17:0 
                   Up 
                 
                     
                     
                   Lyso PC 18:0 
                   Up 
                 
                     
                     
                   C3:1 
                   Up 
                 
                     
                     
                   Lyso PC 16:0 
                   Up 
                 
                     
                     
                   Lyso PC 18:1 
                   Up 
                 
                     
                     
                   C18:2 
                   Up 
                 
                     
                     
                   C14 
                   Up 
                 
                     
                     
                   C18 
                   Up 
                 
                     
                     
                   C18:1 
                   Up 
                 
                     
                     
                   C16 
                   Up 
                 
                     
                     
                   C14:2 
                   Up 
                 
                     
                     
                   Tyrosine 
                   Down 
                 
                     
                     
                   Asparagine 
                   Down 
                 
                     
                     
                   PC ae 36:0 
                   Down 
                 
                     
                     
                   C16:2 
                   Down 
                 
                     
                     
                   Phenylalanine 
                   Down 
                 
                     
                     
                   C16:1 
                   Down 
                 
                     
                     
                   Glutamine 
                   Down 
                 
                     
                     
                   SM 20:2 
                   Down 
                 
                     
                     
                   PC aa 32:2 
                   Down 
                 
                     
                     
                   Isoleucine 
                   Down 
                 
                     
                     
                   Citrulline 
                   Down 
                 
                     
                     
                   Histidine 
                   Down 
                 
                     
                     
                   Glutamate 
                   Down 
                 
                     
                     
                   Methionine-Sulfoxide 
                   Down 
                 
                     
                     
                   Asymmetric 
                   Down 
                 
                     
                     
                   dimethylargine 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         or of the 13 metabolites in Table 35B: 
       
       
         
           
                 
                 
                 
                 
               
                     
                     
                 
                     
                     
                   LYSOC17:0 
                   Up 
                 
                     
                     
                   LYSOC18:0 
                   Up 
                 
                     
                     
                   LYSOC16:0 
                   Up 
                 
                     
                     
                   C18:2 
                   Up 
                 
                     
                     
                   C14 
                   Up 
                 
                     
                     
                   C18:1 
                   Up 
                 
                     
                     
                   C18 
                   Up 
                 
                     
                     
                   C16 
                   Up 
                 
                     
                     
                   Glutamine 
                   Down 
                 
                     
                     
                   Histidine 
                   Down 
                 
                     
                     
                   SM 20:2 
                   Down 
                 
                     
                     
                   Methionine-sulfoxide 
                   Down 
                 
                     
                     
                   Asymmetric dimethylarginine 
                   Down; 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         or
 (a2) in a day 4 sample assessed by MS/MS, wherein at least 2, at least 5, or at least 10 metabolites of said plurality of metabolites are increased or decreased relative to the control as indicated, of the 15 metabolites in Table 36A: 
 
       
       
         
           
                 
                 
                 
                 
               
                     
                     
                 
                     
                     
                   C3OH 
                   Up 
                 
                     
                     
                   Glutamic acid 
                   Up 
                 
                     
                     
                   LYSOC18:0 
                   Up 
                 
                     
                     
                   Ornithine 
                   Up 
                 
                     
                     
                   PC aa3 6:0 
                   Up 
                 
                     
                     
                   C18:2 
                   Up 
                 
                     
                     
                   alpha-Aminoadipic acid 
                   Up 
                 
                     
                     
                   Indole acetic acid 
                   Up 
                 
                     
                     
                   C3:1 
                   Up 
                 
                     
                     
                   PC aa 40:2 
                   Down 
                 
                     
                     
                   C16:1 
                   Down 
                 
                     
                     
                   Serine 
                   Down 
                 
                     
                     
                   Glutamine 
                   Down 
                 
                     
                     
                   beta-Hydroxybutyric acid 
                   Down 
                 
                     
                     
                   Uric acid 
                   Down, 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         
           or of the 11 metabolites in Table 36B: 
         
       
       
         
           
                 
                 
                 
                 
               
                     
                     
                 
                     
                     
                   C3OH 
                   Up 
                 
                     
                     
                   Glutamic acid 
                   Up 
                 
                     
                     
                   LYSOC18:0 
                   Up 
                 
                     
                     
                   Ornithine 
                   Up 
                 
                     
                     
                   PC36:0AA 
                   Up 
                 
                     
                     
                   C18:2 
                   Up 
                 
                     
                     
                   C3:1 
                   Up 
                 
                     
                     
                   C16:1 
                   Down 
                 
                     
                     
                   Glutamine 
                   Down 
                 
                     
                     
                   beta-Hydroxybutyric acid 
                   Down 
                 
                     
                     
                   Uric acid 
                   Down; 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         
           or 
           (b1) in a day 1 sample assessed by proton (1H) nuclear magnetic resonance spectroscopy (NMR), wherein at least 2, at least 5, or at least 10 metabolites of said plurality of metabolites are increased or decreased relative to the control as indicated, of the 12 metabolites in Table 39A: 
         
       
       
         
           
                 
                 
                 
                 
               
                     
                     
                 
                     
                     
                   Ornithine 
                   Up 
                 
                     
                     
                   Glucose 
                   Up 
                 
                     
                     
                   Acetone 
                   Up 
                 
                     
                     
                   Lactate 
                   Up 
                 
                     
                     
                   Glycerol 
                   Up 
                 
                     
                     
                   Betaine 
                   Up 
                 
                     
                     
                   Choline 
                   Up 
                 
                     
                     
                   Serine 
                   Up 
                 
                     
                     
                   Glycine 
                   Up 
                 
                     
                     
                   Formate 
                   Up 
                 
                     
                     
                   Isoleucine 
                   Down 
                 
                     
                     
                   Dimethylamine 
                   Down, 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         
           or at least 5 of the 6 metabolites in Table 39B: 
         
       
       
         
           
                 
                 
                 
                 
               
                     
                     
                 
                     
                     
                   Ornithine 
                   Up 
                 
                     
                     
                   Acetone 
                   Up 
                 
                     
                     
                   Lactate 
                   Up 
                 
                     
                     
                   Glycerol 
                   Up 
                 
                     
                     
                   Betaine 
                   Up 
                 
                     
                     
                   Choline 
                   Up; 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
               
            
           
         
         
           or 
           (b2) in a day 4 sample assessed by NMR, wherein at least 2, or at least 5 metabolites of said plurality of metabolites are increased or decreased relative to the control as indicated, of the 9 metabolites in Table 40A: 
         
       
       
         
           
                 
                 
                 
                 
               
                     
                     
                 
                     
                     
                   Valine 
                   Up 
                 
                     
                     
                   N-Acetylaspartate 
                   Up 
                 
                     
                     
                   Tyrosine 
                   Up 
                 
                     
                     
                   Lysine 
                   Up 
                 
                     
                     
                   Histidine 
                   Up 
                 
                     
                     
                   Dimethyl Sulfone 
                   Up 
                 
                     
                     
                   Pyruvate 
                   Down 
                 
                     
                     
                   Taurine 
                   Down 
                 
                     
                     
                   Gluoconate 
                   Down, 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         
           or of the 6 metabolites in Table 40B: 
         
       
       
         
           
                 
                 
                 
                 
               
                     
                     
                 
                     
                     
                   Valine 
                   Up 
                 
                     
                     
                   N-Acetylaspartate 
                   Up 
                 
                     
                     
                   Tyrosine 
                   Up 
                 
                     
                     
                   Lysine 
                   Up 
                 
                     
                     
                   Taurine 
                   Down 
                 
                     
                     
                   Gluconate 
                   Down; 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
               
            
           
         
       
       or
 (ii) wherein the likelihood of unfavourable outcome at 12 months is determined:
 (c1) in a day 1 sample, assessed by QUANTITATIVE MS, wherein at least 2, at least 5, or at least 10 metabolites of said plurality of metabolites are increased or decreased relative to the control as indicated, of the 21 metabolites in Table 37A: 
 
 
       
         
           
                 
                 
                 
                 
               
                     
                     
                 
                     
                     
                   C5OH 
                   Down 
                 
                     
                     
                   Homocysteine 
                   Up 
                 
                     
                     
                   C3 
                   Up 
                 
                     
                     
                   C0 
                   Up 
                 
                     
                     
                   C4 
                   Up 
                 
                     
                     
                   Ornithine 
                   Up 
                 
                     
                     
                   LYSOC14:0 
                   Up 
                 
                     
                     
                   SM 16:1 OH 
                   Up 
                 
                     
                     
                   LYSOC20:3 
                   Up 
                 
                     
                     
                   LYSOC28:1 
                   Up 
                 
                     
                     
                   C10:2 
                   Down 
                 
                     
                     
                   Acetyl-ornithine 
                   Down 
                 
                     
                     
                   C9 
                   Down 
                 
                     
                     
                   Adimethylarginine 
                   Down 
                 
                     
                     
                   Methionine-sulfoxide 
                   Down 
                 
                     
                     
                   Spermine 
                   Down 
                 
                     
                     
                   PC ae 36:0 
                   Down 
                 
                     
                     
                   Citrulline 
                   Down 
                 
                     
                     
                   Serotonin 
                   Down 
                 
                     
                     
                   Serine 
                   Down 
                 
                     
                     
                   trans-Hydroxyproline 
                   Down 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         
           or of the 15 metabolites in Table 37B: 
         
       
       
         
           
                 
                 
                 
                 
               
                     
                     
                 
                     
                     
                   C3 
                   Up 
                 
                     
                     
                   Ornithine 
                   Up 
                 
                     
                     
                   C0 
                   Up 
                 
                     
                     
                   SM 16:1 OH 
                   Up 
                 
                     
                     
                   LYSOC14:0 
                   Up 
                 
                     
                     
                   LYSOC20:3 
                   Up 
                 
                     
                     
                   Homocysteine 
                   Up 
                 
                     
                     
                   Serotonin 
                   Down 
                 
                     
                     
                   C9 
                   Down 
                 
                     
                     
                   PC ae 36:0 
                   Down 
                 
                     
                     
                   Methionine-sulfoxide 
                   Down 
                 
                     
                     
                   Serine 
                   Down 
                 
                     
                     
                   Adimethylarginine 
                   Down 
                 
                     
                     
                   Spermine 
                   Down 
                 
                     
                     
                   trans-Hydroxyproline 
                   Down; 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         
           or 
           (c2) in a day 4 sample, assessed by quantitative MS, wherein at least 2, at least 5, or at least 10 metabolites of said plurality of metabolites are increased or decreased relative to the control as indicated, of the 18 metabolites in Table 38A: 
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   C6 
                   Up 
                 
                     
                   C3 OH 
                   Up 
                 
                     
                   C18:1 OH 
                   Up 
                 
                     
                   Tryptophan 
                   Up 
                 
                     
                   C3:1 
                   Up 
                 
                     
                   Tyrosine 
                   Up 
                 
                     
                   Creatinine 
                   Up 
                 
                     
                   LysoPC 14:0 
                   Up 
                 
                     
                   Alanine 
                   Up 
                 
                     
                   C16 
                   Up 
                 
                     
                   C2 
                   Down 
                 
                     
                   C14 
                   Down 
                 
                     
                   Beta-hydroxy butyric 
                   Down 
                 
                     
                   Spermine 
                   Down 
                 
                     
                   Betaine 
                   Down 
                 
                     
                   C14:2 
                   Down 
                 
                     
                   Aspartic acid 
                   Down 
                 
                     
                   C18 
                   Down 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         
           or of the 13 metabolites in Table 38B: 
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   C6 
                   Up 
                 
                     
                   C3 OH 
                   Up 
                 
                     
                   Tryptophan 
                   Up 
                 
                     
                   C3:1 
                   Up 
                 
                     
                   Tyrosine 
                   Up 
                 
                     
                   Creatinine 
                   Up 
                 
                     
                   LysoPC 14:0 
                   Up 
                 
                     
                   C14 
                   Down 
                 
                     
                   Beta-hydroxy butyric 
                   Down 
                 
                     
                   Betaine 
                   Down 
                 
                     
                   C14:2 
                   Down 
                 
                     
                   Aspartic acid 
                   Down 
                 
                     
                   C18 
                   Down; 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         
           or 
           (d1) in a day 1 sample assessed by NMR, wherein at least 2, or at least 5 metabolites of said plurality of metabolites are increased or decreased relative to the control as indicated, of the 8 metabolites in Table 41A: 
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   Ornithine 
                   Up 
                 
                     
                   Valine 
                   Up 
                 
                     
                   Succinate 
                   Up 
                 
                     
                   Leucine 
                   Up 
                 
                     
                   Gluconate 
                   Up 
                 
                     
                   Alanine 
                   Up 
                 
                     
                   Mannose 
                   Down 
                 
                     
                   3-Hyroxyisovalerate 
                   Down, 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
               
            
           
         
         
           or at least 4 of the 5 metabolites in Table 41B: 
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   Ornithine 
                   Up 
                 
                     
                   Succinate 
                   Up 
                 
                     
                   Gluconate 
                   Up 
                 
                     
                   Alanine 
                   Down 
                 
                     
                   3-Hyroxyisovalerate 
                   Down; 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
               
            
           
         
         
           or 
           (d2) in a day 4 sample assessed by NMR, wherein at least 2, or at least 5 metabolites of said plurality of metabolites are increased or decreased relative to the control as indicated, of the 9 metabolites in Table 42A: 
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   Dimethyl sulfone 
                   Up 
                 
                     
                   Tyrosine 
                   Up 
                 
                     
                   Hisitidine 
                   Up 
                 
                     
                   Valine 
                   Up 
                 
                     
                   Leucine 
                   Up 
                 
                     
                   Taurine 
                   Up 
                 
                     
                   Hypoxanthine 
                   Down 
                 
                     
                   Isopropanol 
                   Down 
                 
                     
                   Beta-alanine 
                   Down, 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         
           or of the 5 metabolites in Table 42B: 
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   Dimethyl sulfone 
                   Up 
                 
                     
                   Tyrosine 
                   Up 
                 
                     
                   Valine 
                   Up 
                 
                     
                   Hypoxanthine 
                   Down 
                 
                     
                   Beta-alanine 
                   Down; 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
               
            
           
         
       
       or
 (iii) wherein the likelihood of mortality outcome is determined:
 (e1) in a day 1 sample, assessed by quantitative MS, wherein at least 2, at least 5, or at least 10 metabolites of said plurality of metabolites are increased or decreased relative to the control as indicated, of the 19 metabolites in Table 43A: 
 
 
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   C3:1 
                   Up 
                 
                     
                   PC aa 38:0 
                   Up 
                 
                     
                   Glucose 
                   Up 
                 
                     
                   PC ae 40:6 
                   Up 
                 
                     
                   C10:1 
                   Up 
                 
                     
                   C14:1 
                   Up 
                 
                     
                   C14 
                   Up 
                 
                     
                   C10 
                   Up 
                 
                     
                   C16:2 
                   Up 
                 
                     
                   C8 
                   Up 
                 
                     
                   C12 
                   Up 
                 
                     
                   Citrulline 
                   Down 
                 
                     
                   C10:2 
                   Down 
                 
                     
                   Leucine 
                   Down 
                 
                     
                   Valine 
                   Down 
                 
                     
                   Isoleucine 
                   Down 
                 
                     
                   Histidine 
                   Down 
                 
                     
                   C16 OH 
                   Down 
                 
                     
                   Glutamine 
                   Down 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         
           or of the 11 metabolites in Table 43B; 
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   C3:1 
                   Up 
                 
                     
                   PC aa 38:0 
                   Up 
                 
                     
                   Glucose 
                   Up 
                 
                     
                   C16:2 
                   Up 
                 
                     
                   Leucine 
                   Down 
                 
                     
                   C10:2 
                   Down 
                 
                     
                   Valine 
                   Down 
                 
                     
                   Isoleucine 
                   Down 
                 
                     
                   Histidine 
                   Down 
                 
                     
                   C16 OH 
                   Down 
                 
                     
                   Glutamine 
                   Down; 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         
           or 
           (e2) in a day 4 sample, assessed by quantitative MS, wherein at least 2, at least 5, or at least 10 metabolites of said plurality of metabolites are increased or decreased relative to the control as indicated, of the 22 metabolites in Table 44A: 
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   Indole acetic acid 
                   Up 
                 
                     
                   Alpha-Ketglutaric acid 
                   Up 
                 
                     
                   Hippric acid 
                   Up 
                 
                     
                   C16:2 OH 
                   Up 
                 
                     
                   Ornithine 
                   Up 
                 
                     
                   PC aa 36:0 
                   Up 
                 
                     
                   C3 
                   Up 
                 
                     
                   Threonine 
                   Up 
                 
                     
                   Alpha-Aminoadipic acid 
                   Up 
                 
                     
                   PC aa 38:0 
                   Up 
                 
                     
                   Tyrosine 
                   Up 
                 
                     
                   Valine 
                   Up 
                 
                     
                   Tryptophan 
                   Up 
                 
                     
                   C2 
                   Down 
                 
                     
                   C8 
                   Down 
                 
                     
                   C12:1 
                   Down 
                 
                     
                   Betaine 
                   Down 
                 
                     
                   C6 
                   Down 
                 
                     
                   Glutamine 
                   Down 
                 
                     
                   Taurine 
                   Down 
                 
                     
                   LysoPC 26:0 
                   Down, 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         
           or of the 16 metabolites in Table 44B: 
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   Alpha-Ketoglutaric acid 
                   Up 
                 
                     
                   C16:2 OH 
                   Up 
                 
                     
                   Hippuric acid 
                   Up 
                 
                     
                   Indole acetic acid 
                   Up 
                 
                     
                   PC aa 36:0 
                   Up 
                 
                     
                   Ornithine 
                   Up 
                 
                     
                   PC aa 38:0 
                   Up 
                 
                     
                   Alpha-Aminoadipic acid 
                   Up 
                 
                     
                   Tryptophan 
                   Up 
                 
                     
                   Valine 
                   Down 
                 
                     
                   Leucine 
                   Down 
                 
                     
                   C12:1 
                   Down 
                 
                     
                   C6 
                   Down 
                 
                     
                   Glutamine 
                   Down 
                 
                     
                   LysoPC 26:0 
                   Down 
                 
                     
                   Taurine 
                   Down; 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         
           or 
           (f1) in a day 1 sample, assessed by NMR, wherein at least 2, at least 5, or at least 10 metabolites of said plurality of metabolites are increased or decreased relative to the control as indicated, of the 17 metabolites in Table 45A: 
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   Glucose 
                   Up 
                 
                     
                   Betaine 
                   Up 
                 
                     
                   3-Hydroxyisovalerate 
                   Up 
                 
                     
                   Citrate 
                   Up 
                 
                     
                   O-Phosphocholine 
                   Up 
                 
                     
                   Dimethyl Sulfone 
                   Up 
                 
                     
                   Formate 
                   Up 
                 
                     
                   Fumarte 
                   Up 
                 
                     
                   2-Oxglutarate 
                   Up 
                 
                     
                   Pyruvate 
                   Up 
                 
                     
                   Lactate 
                   Down 
                 
                     
                   Valine 
                   Down 
                 
                     
                   Isoleucine 
                   Down 
                 
                     
                   Leucine 
                   Down 
                 
                     
                   Diemthylamine 
                   Down 
                 
                     
                   Glutamine 
                   Down 
                 
                     
                   Histidine 
                   Down, 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         
           or at least 4 of the 5 metabolites in Table 45B: 
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   Glucose 
                   Up 
                 
                     
                   Betaine 
                   Up 
                 
                     
                   3-Hydroxyisovalerate 
                   Up 
                 
                     
                   Citrate 
                   Up 
                 
                     
                   Lactate 
                   Down; 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
               
            
           
         
         
           or 
           (f2) in a day 4 sample, assessed by NMR, wherein at least 2, or at least 5 metabolites of said plurality of metabolites are increased or decreased relative to the control as indicated, of the 16 metabolites in Table 46A: 
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   Isobutyrate 
                   Up 
                 
                     
                   Creatine 
                   Up 
                 
                     
                   Creatinine 
                   Up 
                 
                     
                   Valine 
                   Up 
                 
                     
                   Lysine 
                   Up 
                 
                     
                   Asparagine 
                   Up 
                 
                     
                   Leucine 
                   Up 
                 
                     
                   Tyrosine 
                   Up 
                 
                     
                   2-Aminobutyrate 
                   Up 
                 
                     
                   4-Hydroxybutyrate 
                   Down 
                 
                     
                   Methionine 
                   Down 
                 
                     
                   Urea 
                   Down 
                 
                     
                   Hypoxanthine 
                   Down 
                 
                     
                   Taurine 
                   Down 
                 
                     
                   Gluconate 
                   Down 
                 
                     
                   Betaine 
                   Down, 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         
           of the 8 metabolites in Table 46B: 
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   Isobutyrate 
                   Up 
                 
                     
                   Valine 
                   Up 
                 
                     
                   Lysine 
                   Up 
                 
                     
                   2-Aminobutyrate 
                   Up 
                 
                     
                   Hypoxanthine 
                   Down 
                 
                     
                   Taurine 
                   Down 
                 
                     
                   Gluconate 
                   Down 
                 
                     
                   Betaine 
                   Down, 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
               
            
           
         
         
           or at least 2 or 4 of the 5 metabolites in Table 46C: 
         
       
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   Valine 
                   Up 
                 
                     
                   Lysine 
                   Up 
                 
                     
                   Taurine 
                   Down 
                 
                     
                   Gluconate 
                   Down 
                 
                     
                   Betaine 
                   Down. 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
               
            
           
         
       
     
     
         10 . The method of  claim 9 , wherein said likelihood of said unfavorable outcome is predicted for three months following the sTBI. 
     
     
         11 . The method of  claim 9 , wherein said likelihood of said unfavorable outcome is predicted for twelve months following the sTBI. 
     
     
         12 . The method of  claim 9 , wherein said likelihood of mortality is predicted. 
     
     
         13 . The method of any one of  claims 1 to 12 , wherein sample is a serum sample. 
     
     
         14 . The method of any one of  claims 1 to 13 , wherein the control is a value determined from individuals with an orthopedic injury (OI) without head injury, or from a cohort of individuals with sTBI having a favorable outcome. 
     
     
         15 . The method of any one of  claims 1 to 14 , wherein said amount of said plurality of metabolites are assessed by NMR. 
     
     
         16 . The method of any one of  claims 1 to 14 , wherein said amount of said plurality of metabolites are assessed by quantitative MS. 
     
     
         17 . The method of any one of  claims 1 to 16 , wherein said sample is obtained at day 1 following the sTBI. 
     
     
         18 . The method of any one of  claims 1 to 16 , wherein said sample is obtained at day 4 following the sTBI. 
     
     
         19 . The method of any one of  claims 1 to 12 , wherein said sample is obtained at day 1 and day 4 following the sTBI. 
     
     
         20 . The method of  claim 9 , wherein the likelihood of unfavourable outcome at 3 months is determined by assessing the increase or decrease in the following metabolites:
 (a1) in a day 1 sample, assessed by quantitative MS wherein the metabolites are increased or decreased as indicated in Table 35A or Table 35B;   (a2) in a day 4 sample, assessed by quantitative MS wherein the metabolites are increased or decreased as indicated in Table 36A or Table 36B;   (b1) in a day 1 sample, assessed by NMR wherein the metabolites are increased or decreased as indicated in Table 39A or Table 39B; or   (b2) in a day 4 sample, assessed by NMR wherein the metabolites are increased or decreased as indicated in Table 40A or Table 40B.   
     
     
         21 . The method of  claim 9 , wherein the likelihood of unfavourable outcome at 12 months is determined by assessing the increase or decrease in the following metabolites:
 (c1) in a day 1 sample, assessed by quantitative MS wherein the metabolites are increased or decreased as indicated in Table 37A or Table 37B;   (c2) in a day 4 sample, assessed by quantitative MS wherein the metabolites are increased or decreased as indicated in Table 38A or Table 38B;   (d1) in a day 1 sample, assessed by NMR wherein the metabolites are increased or decreased as indicated in Table 41A or Table 41B; or   (d2) in a day 4 sample, assessed by NMR wherein the metabolites are increased or decreased as indicated in Table 42A or Table 42B.   
     
     
         22 . The method of  claim 9 , wherein the likelihood of mortality outcome at 3 months is determined by assessing the increase or decrease in the following metabolites:
 (e1) in a day 1 sample, assessed by quantitative MS wherein the metabolites are increased or decreased as indicated in Table 43A or Table 43B;   (e2) in a day 4 sample, assessed by quantitative MS wherein the metabolites are increased or decreased as indicated in Table 44A or Table 44B;   (f1) in a day 1 sample, assessed by NMR wherein the metabolites are increased or decreased as indicated in Table 45A or Table 45B; or   (f2) in a day 4 sample, assessed by NMR wherein the metabolites are increased or decreased as indicated in Table 46A, Table 46B, or Table 46C.   
     
     
         23 . The method of  claim 9 , wherein the likelihood of mortality outcome at 3 months is determined by assessing the increase or decrease in metabolites:
 (e1) in a day 1 sample, assessed by quantitative MS wherein the metabolites are increased or decreased as indicated in Table 43B;   (e2) in a day 4 sample, assessed by quantitative MS wherein the metabolites are increased or decreased as indicated in Table 44B;   (f1) in a day 1 sample, assessed by NMR wherein the metabolites are increased or decreased as indicated in Table 45B; or   (f2) in a day 4 sample, assessed by NMR wherein the metabolites are increased or decreased as indicated in Table 46C.   
     
     
         24 . A kit for predicting outcome of a traumatic brain injury in a subject comprising:
 reagents for detecting the metabolites listed in any one of Tables 35A, 35B, 36A, 36B, 37A, 37B, 38A, 38B, 39A, 39B, 40A, 40B, 41A, 41B, 42A, 42B, 43A, 43B, 44A, 44B, 45A, 45B, 46A, 46B, or 46C, and   instructions for conducting the method of any one of claims  1  to  23 .

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